Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.
Information
Type
Proposed Rule
Regulated products
Published
March 25, 2013
Last updated
March 25, 2013
Description
Document number 2013-06723. The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments devices: Automated external defibrillators systems (AEDs), which includes the AED device and its accessories (i.e., pad electrodes, batteries, and adapters). The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's premarket approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the automated external defibrillator based on new information. This action implements certain statutory requirements.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)